Intermune's IPF drug follows bringer's "breakthrough" certification by FDA

Source: on July 21, 2014, a drug being developed by dingxiangyuan company for the treatment of rare lung diseases was recognized by FDA as a breakthrough therapy It was tied with bringer Ingelheim, and the two companies will each occupy a corner of the U.S market Intermune's drug, pirfenidone, is used to treat often fatal idiopathic pulmonary fibrosis (IPF), a scarring disease that inhibits the body's absorption of oxygen, leading to poor breathing and rapid lung function FDA's breakthrough label ensures that the drug is reviewed quickly and submitted to the agency's senior audit team, but intermune does not expect the time when the drug will be approved In an email, intermune said pirfenidone had won the FDA's commitment to priority review, and adding a breakthrough certification label would not affect the speed of the agency's review But despite that, the FDA's commitment to "mobilise US FDA executives and provide additional resources to coordinate interdisciplinary reviews" could speed up the review, but intermune said it was entirely up to the agency to decide Intermune expects to get approval for pirfenidone by November, if everything goes as planned to launch the drug in the first quarter of 2015 The breakthrough mark was only one day later than that of bringer ingelham, a rival of intermune in the field of IPF treatment, who also received the same recognition Like the two companies, bringer's nintedanib has won a priority review, but the German drugmaker did not disclose the expected timeline for approval Intermune's drug was rejected by the FDA as early as 2010, but after the company resubmitted some new and valuable phase 3 data, the biotech company won back the review agency's favor and resubmitted the drug for review in May About 40000 people die each year from IPF, but there are no FDA approved drugs in the field, according to the pulmonary fibrosis Association Pirfenidone has been sold in overseas markets for several years, but has not generated any significant sales momentum, bringing only $70.2 million last year Analysts speculate that the peak value of IPF drug market in the United States will exceed 2 billion, but intermune or bringer both claim that whether there is such a large market share needs to be discussed At present, the two drugs have achieved good results in three trials, but both of them have missed at least one secondary end point in later trials Pirfenidone plays a role by inhibiting two kinds of cytokines, one is TGF - β, which controls the transformation of cell function and is also a part of fibrosis, the other is TNF - α, which plays an active role in inflammation In a key study, the drug significantly delayed lung failure compared with placebo, and the six minute walk trial also reached a secondary end point Original link: http://